BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL TEST

    MDR report key: 1893854 · Received November 1, 2010

    Report

    Report Number
    2027969-2010-01844
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 8, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED POTENTIAL FALSE POSITIVE TROPONIN I (TNI) RESULTS ON PT SAMPLES RUN ON TRIAGE CARDIAC PANEL TEST. CUSTOMER REPORTS 4 SAMPLES DRAWN FOR PT OVER 2 DAY PERIOD. ALL SAMPLES RERUN TWICE ON (B)(6) 2010 IN AFTERNOON WITH TRIAGE METER AND SHOWED VARYING RESULTS FROM THOSE FIRST SEEN. ALL TESTS PERFORMED ON WHOLE BLOOD. TWO SAMPLES FROM OTHER PTS WERE RETESTED AND RESULTS WERE THE SAME OR SIMILAR TO ORIGINAL VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL TEST CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. 97000HS W47736

    Patients

    Seq Age Sex Outcome Treatment
    1